Added Value of Superior Vena Cava Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Recurrence of atrial tachyarrhythmia 1 year after the index ablation
研究概览
简要总结
Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear.
With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Patients scheduled for a repeat ablation of PAF after a previous PVI
- •PV reconnection (in ≥1 PV's) found during procedure at the time of randomization
排除标准
- •Patients with persistent AF
- •Patients with durable PVI (no PVR)
- •Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
- •Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
- •Left ventricular ejection fraction <35%.
- •Cardiac surgery within the previous 90 days.
- •Expecting cardiac transplantation or other cardiac surgery within 180 days.
- •Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
- •Documented history of a thromboembolic event within the previous 90 days.
- •Diagnosed atrial myxoma.
- •Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- •Women who are pregnant or who plan to become pregnant between signing the informed consent form and the index ablation.
- •Acute illness or active infection at time of index procedure
- •Advanced renal insufficiency
- •Unstable angina.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation.
- •Life expectancy less than 1 year.
- •Presence of a condition that precludes vascular access.
- •INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
- •Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
- •Unwilling or unable to provide informed consent.
研究组 & 干预措施
PVI only group
Patients allocated to this group will receive PV re-isolation alone
干预措施: PVI (Procedure)
PVI + SVC group
Patients allocated to this group will receive PV re-isolation with SVC isolation.
干预措施: PVI + SVC (Procedure)
结局指标
主要结局
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
时间窗: 1 year after ablation
Measured on 72hr Holter monitoring
Safety measured by procedural complications
时间窗: From time of ablation to 1 month post procedure
Occurence of procedural complications post procedure
次要结局
- Total procedure time(At time of ablation)
- Fluoroscopy time(At time of ablation)
- RF ablation time(At time of ablation)
- Atrial volume(At time of ablation)
- SVC width(At time of ablation)
- phrenic nerve width(At time of ablation)
研究者
Sebastien Knecht
Professor Doctor
AZ Sint-Jan AV